Abortion pill declared safe despite 3 deaths

The FDA says RU-486 can stay on the market with expanded warning

Published 4:30 am, Wednesday, November 17, 2004

WASHINGTON - The abortion pill RU-486 is safe enough to remain on the market with strengthened warnings, the government said Tuesday despite a third death after the drug's use.

Critics said scrutiny of the drug would only increase. "I think you'll see the opposition, but not just from people who are pro-life," said Wendy Wright, senior policy director at Concerned Women for America. "This is a dangerous drug."

"It is my hope that women will not be afraid" to use mifepristone, originally known as RU-486, to induce abortion, said Vanessa Cullins, vice president for medical affairs at Planned Parenthood Federation of America. "All of us need to understand that no procedure, no medication, is risk-free."

"There was absolutely no political pressure," Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, said when asked if the Bush administration had weighed in. "This was a science-based decision."

At least three women who took the pill in the United States have died, although the FDA says it has not definitively tied any death to use of the pill.

Those three deaths were among 676 adverse events reported through Nov. 5 by women who used the abortion pill. The problems included sickness and dizziness as well as more serious illnesses that required hospitalization, according to the FDA.

Seventeen women used RU-486 even though they had tubal pregnancies; the drug is not to be used by women with suspected or confirmed ectopic pregnancies, in which the fertilized egg has implanted outside the uterus.

Another 72 women bled so heavily after using the abortion pill that they required transfusions. Seven women suffered serious bacterial infections, including sepsis.

"We are concerned about any drug that is related to serious medical complications and, certainly, death," Galson said.

Still, infection, bleeding and death can accompany abortion, whether accomplished by surgery or medication. The same events can happen during childbirth.

An attorney who represented the estate of a Tennessee woman who died in 2001 said the agency could do more. The FDA could prohibit RU-486 use until doctors rule out tubal pregnancies, which are difficult to detect in the first five weeks, said the attorney, Hoyt Samples.

Brenda Vise, a 38-year-old former nurse, died in the hospital where she once worked after a ruptured tubal pregnancy. In eight to 10 calls over two days to the clinic that gave her RU-486, she was told the severe pain and cramps she felt were normal.

"The real problem is the use of this drug masks symptoms of ectopic pregnancies," Samples said.